The purpose of this study is to investigate monitoring methods during ovulation induction cycles with letrozole and their effect on pregnancy rates. Monitoring ovulation induction cycles with letrozole can be done with a variety of methods, the two most commonly utilized are home-based urinary LH kits (or ovulation predictor kits) and office-based midcycle follicular ultrasound. Letrozole coupled with follicular monitoring by ultrasound may add extra cost per cycle with no improvement in fecundability (pregnancy rates per cycle).

Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination.

Other Name: ClearBlue Easy

Active Comparator: Midcycle ultrasound + hCG injection

Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.

Other: Midcycle ultrasound + hCG injection

Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate.

Other Name: Ovidrel

Detailed Description:

The study will be a randomized controlled trial of adult women with primary and secondary infertility seen at the University of Michigan Health System undergoing ovulation induction (OI) with letrozole as part of their standard clinical care. Patients who are undergoing OI with letrozole as per standard clinical care will be randomized to urinary luteinizing hormone (LH) ovulation predictor kit use versus mid-cycle ultrasound with administration of hCG when appropriate for timing of intercourse or intrauterine insemination. Patients who have been prescribed letrozole as per routine clinical care will be approached to determine willingness to participate in this study. Study period involves up to three ovulation induction cycles or until pregnancy occurs.

Previous letrozole or gonadotropin use and/or previous treatment with in vitro fertilization

Other uncorrected medical condition that would be a contraindication to attempting elective ovulation induction (e.g., uncontrolled diabetes, intracranial lesion, thyroid or adrenal disease).

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279200